1. Field of the Invention
The present invention relates to a composition for the prophylaxis and/or treatment of diaper dermatitis or similar dermal irritation and methods for making and using the composition.
More particularly, the present invention relates to a composition including an enzyme inhibitor system, a sacrificial substrate system or a combined system for the prophylaxis and/or treatment of tissue irritation due to enzyme activity, especially protease and lipase enzyme activity, and methods for making and using such compositions. The compositions of the present invention are especially useful in inhibiting the activity of lipase and protease enzymes present in expressed feces that cause diaper dermatitis or similar dermal conditions or in tissues exposed to bodily fluids or any fluid containing lipase and protease enzymes or the exposure of tissues to any composition (solid, liquid, emulsion, dispersion, etc.) containing lipase and protease enzymes.
2. Description of the Related Art
Diaper dermatitis is a phenomenon frequently encountered by parents of small children or by patients in nursing homes who are required to wear a diaper. Although the dermatitis is treatable, occurrence and persistence often results in unhappy children and sleep deprived parents. In severe cases, it results in painful decubitus ulcers. Many ointments and powders exist on the market for treating and preventing diaper dermatitis, but most function by merely forming a barrier between the skin and expressed feces.
Thus, it would represent an advancement in the art to provide compositions and methods for their preparation and use which prevent the chemical and biological reactions that cause diaper dermatitis.
The present invention addresses these needs by providing a composition for treating or preventing diaper dermatitis, where the composition includes an enzyme inhibitor system, a sacrificial substrate system or mixtures or combinations thereof. The inhibitor system inhibits enzymatic activity caused by human feces that comes in contact with a portion of skin of a human adult or child after fecal expression or to deactivate enzymes in fecal matter that can irritate skin. Preferably, the enzyme inhibitor system includes a lipase inhibitor and/or a protease inhibitor or compounds capable of deactivating either lipases and/or proteases present in fecal matter. The sacrificial substrate system decreases or prevents enzymatic attack of portions of skin of the animal or human (adult or child) that comes in contact with expressed fecal material. Preferably, the sacrificial substrate system includes a lipase substrate and/or a protease substrate.
The present invention also provides a medication including a therapeutically effective amount of an enzyme inhibitor system, a sacrificial substrate system or mixtures or combinations thereof in a carrier, where the inhibitor system inhibits enzymatic activity caused by human feces that comes in contact with a portion of skin of a human adult or child after fecal expression and the sacrificial substrate system decreases or prevents enzymatic attack of portions of skin of the animal or human (adult or child) that comes in contact with expressed fecal material.
The present invention also provides a topical ointment including a therapeutically effective amount of an enzyme inhibitor system, a sacrificial substrate system or mixtures or combinations thereof in a carrier, where the inhibitor system inhibits enzymatic activity caused by human feces that come in contact with a portion of skin of a human adult or child after fecal expression and the sacrificial substrate system decreases or prevents enzymatic attack of portions of skin of the animal or human (adult or child) that comes in contact with expressed fecal material.
The present invention also provides a medicated powder including a carrier powder and a therapeutically effective amount of an enzyme inhibitor system, a sacrificial substrate system or mixtures or combinations thereof, where the inhibitor system is designed to inhibit enzymatic activity caused by human feces that comes in contact with a portion of skin of a human adult or child after fecal expression and the sacrificial substrate system decreases or prevents enzymatic attack of portions of skin of the animal or human (adult or child) that comes in contact with expressed fecal material.
The present invention also provides a wipe including a therapeutically effective amount of an enzyme inhibitor system, a sacrificial substrate system or mixtures or combinations thereof contained in a composition deposited on an outer surface or incorporated within the matrix or composition of the wipe, where the inhibitor system is designed to inhibit enzymatic activity caused by human feces that comes in contact with a portion of skin of a human adult or child after fecal expression and the sacrificial substrate system decreases or prevents enzymatic attack of portions of skin of the animal or human (adult or child) that comes in contact with expressed fecal material.
The present invention also provides a disposable diaper (adult or infant) including a therapeutically effective amount of an enzyme inhibitor system, a sacrificial substrate system or mixtures or combinations thereof contained in a composition deposited on an outer surface layer or incorporated within the matrix or compositions of the diaper, where the inhibitor system is designed to inhibit enzymatic activity present in human feces that comes in contact with a portion of skin of a human adult or child after fecal expression and the sacrificial substrate system decreases or prevents enzymatic attack of portions of skin of the animal or human (adult or child) that comes in contact with expressed fecal material.
The present invention also provides disposable training pants including a therapeutically effective amount of an enzyme inhibitor system, a sacrificial substrate system or mixtures or combinations thereof contained in a composition deposited on an outer surface layer or incorporated within the matrix or compositions of the training pants, where the inhibitor system is designed to inhibit enzymatic activity, preferably lipase and protease activity, present in human feces that comes in contact with a portion of skin of a human adult or child after fecal expression and the sacrificial substrate system decreases or prevents enzymatic attack of portions of skin of the animal or human (adult or child) that comes in contact with expressed fecal material.
The present invention further provides a method for preventing or treating diaper dermatitis including the step of contacting an area of skin of an adult or child in frequent contact with expressed feces with a composition including an effective amount of an enzyme inhibitor system, a sacrificial substrate system or mixtures or combinations thereof, where the composition inhibits or reduces skin irritation and the resulting dermatitis caused by fecal enzymes.
The present invention further provides a method for preventing or treating diaper dermatitis including the step of applying a composition including an effective amount of an enzyme inhibitor system, a sacrificial substrate system or mixtures or combinations thereof, where the composition reduces irritation and the resulting dermatitis of areas of skin of an adult or child in frequent contact with expressed feces due to enzymes present in fecal matter.
The present invention further provides a method for preventing or treating diaper dermatitis including the step of administering a composition including an effective amount of an enzyme inhibitor system, a sacrificial substrate system or mixtures or combinations thereof, where the composition reduces irritation and the resulting dermatitis of areas of skin of an adult or child in frequent contact with expressed feces due to enzymes present in fecal matter.
The present invention further provides a method for preventing or treating diaper dermatitis including the step of periodically administering a dose of a composition of the present invention sufficient to inhibit or reduce diaper dermatitis.
The present invention further provides a method for preparing a composition for preventing or treating diaper dermatitis including the step of mixing into a physical and/or chemical carrier an effective amount of an enzyme inhibitor system system, a sacrificial substrate system or mixtures or combinations thereof.